No FDA Warnings for Prolia Femur Fractures

January 3, 2013 — The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have not issued warnings about the risk of atypical femur fractures associated with the osteoporosis drug Prolia (denosumab), despite the fact that the drug is sold Europe and the United States.

In November 2012, a health advisory was published by Health Canada. No cases of Prolia femur fractures had been reported in the country. The drug company that manufactures Prolia, Amgen, has updated the side effect information on the drug and sent a letter to doctors to warn about the risk.

During clinical trials of Prolia, researchers confirmed cases of atypical femur fractures in patients being treated with Prolia. Although the cases were rare (less than one out of 10,000 people on the drug), the fractures can occur with little or no warning.

Health experts recommend that patients who are taking Prolia should be aware of the symptoms of a femur fracture, including unusual pain in the hip, thigh, or groin area. Patients should seek medical attention if they suffer these symptoms, and they should be evaluated for an incomplete femur fracture. Pain may occur several weeks before a complete fracture.

The problem with Prolia is similar to that of Fosamax and other drugs used to treat osteoporosis. The drugs suppress bone remodeling, which can potentially contribute to severe bone injuries, including Osteonecrosis of the Jaw (ONJ), atypical femur fractures, and delayed healing of fractures that occur. Merck, the manufacturer of Fosamax, is currently facing hundreds of lawsuits from people who suffered these injuries.

Prolia is a twice-yearly injectable medication that is used to reduce the risk of bone fractures in post-menopausal women who are at risk of bone fractures due to osteoporosis. It can also increase bone mass.

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